ExCR's Effects and Safety in Vulnerable ADHF Patients

YE Jing

Status: Not yet enrolling

Conditions: Acute Decompensated Heart Failure (ADHF)

Treatments: Behavioral: Exercise rehabilitation; Behavioral: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06795737

Peaking UFH

Details and patient eligibility

About

Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.

This study aims to address the following issues:

Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.

The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.

Participants will:

Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.

The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.

At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Hospitalized for ADHF for over 24 hours.
2. Age 18-80 years.
3. At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
4. At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
5. Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).

Exclusion criteria

1. Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
2. Cardiogenic shock.
3. Recent deep vein thrombosis.
4. Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
5. GFR <30 ml/min or need for dialysis during the study.
6. Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted).
7. Severe frailty (Clinical Frailty Scale CFS ≥7).
8. Mental, psychological, cognitive disorders, or substance dependence.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Experimental group

Experimental group

Description:

Exercise rehabilitation

Treatment:

Behavioral: Exercise rehabilitation

Control group

Sham Comparator group

Description:

Conventional rehabilitation

Treatment:

Behavioral: Conventional rehabilitation